Status:
COMPLETED
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
Non HIV Infected Pregnant Women
Eligibility:
FEMALE
21-50 years
Phase:
PHASE4
Brief Summary
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resi...
Detailed Description
The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resi...
Eligibility Criteria
Inclusion
- Pregnant women between 16-28 weeks of gestation;
- Residence within the catchment's area of the health facility;
- Willing to deliver at the health facility;
- Willing to ; adhere to all requirements of the study;
- Willing to provide written informed consent;
- Aged 21 years and above
Exclusion
- Severe anemia (Hb \< 6 g/dL)
- History of allergic reactions to sulfa drugs;
- Taking other sulfa drugs as CTX;
- History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Any significant illness that requires hospitalization;
- Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
- Prior enrollment in the study or concurrent enrollment in another study
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
1717 Patients enrolled
Trial Details
Trial ID
NCT00372632
Start Date
December 1 2005
End Date
April 1 2008
Last Update
September 14 2010
Active Locations (1)
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1
Programme Nationale de Controle de Paludisms
Kigali, Rwanda